Exclusive: Apple is now rejecting new medical apps that include drug dosages

In lieu of the FDA’s recent inquiry into the uCheck urine analyzer app, it appears Apple might be tightening restrictions on medical app developers.

It appears that a number of developers have struggled recently to get medical applications into the App Store with the reason below being cited.

Below is the response developers have told iMedicalApps:

One developer noted that they have now had multiple apps rejected from the App Store and as a result have decided to stop developing for the iOS platform and are going to instead concentrate on the Android platform.

This has many implications for healthcare professionals and patients alike.

The ability to look up a drug dosage on a mobile device is one of the main reasons healthcare professionals use a mobile device. At this point, it’s unclear if apps like Epocrates or Medscape are free from the Section 1.2 rule since they could argue they are using dosage information from the medicine’s manufacturer. But how does Apple confirm the dosages are correct?

Many medical textbook apps contain information related to dosing. Does this mean Apple will reject a textbook app if one part of it contains any drug information?

Only allowing applications which have been developed by pharmaceutical companies opens up the potential for biased medical information and targeted advertising

What happens to medications that are off brand, do we need hundreds of different applications to tell us how to prescribe Tylenol?

What I’m most concerned about is the following: We often prescribe off label use of medications — especially in the pediatric population. The manufacturers often don’t have clear guidelines for the administration of the dosages. Does this mean we won’t be able to look up dosages within apps?

And then more general concerns:

What will happen to existing apps containing dosing information?

Who is going to verify the information contained in each of the apps?

As mentioned at the beginning, this might be a knee jerk reaction by Apple to the recent crackdown on medical applications by the FDA as noted in the recent uCheck incident. Or, this could be an existing rule that Apple is only selectively enforcing.

iMedicalApps has reached out to Apple for a comment we will let our readers know if we get a response. We will continue to follow this story as it unfolds.

Tom Lewis is a co-author on this piece.

Author:

Iltifat Husain, MD

Founder, Editor-in-Chief of iMedicalApps.com. Assistant Professor of Emergency Medicine at Wake Forest University School of Medicine. He is also the CEO and founder of Decision Point Informatics, a human informatics company that helps hospitals reduce unnecessary healthcare testing -- their first product is the Heart Pathway App that integrates into EPIC and Cerner. He went to North Carolina State University for undergrad and went to medical school at Wake Forest School of Medicine.

More than one medical app has been rejected for this reason. We are trying to protect the app developers that have reached out to us so are being vague. The larger point is the discovery that apple has this clause in the app review process, something that has not been reported before.

Fair enough, but the focus on your article isn’t on the “discovery” of the rule (which has been in their guidelines for a while) but rather that this is somehow a widespread problem. Moreover, uCheck was flagged by the FDA not because they had an app, but because it wasn’t reviewed by the FDA first. Apple has no culpability there. And, because 1 or 2 devs were rejected, I’d hardly say Apple is “now rejecting new medical apps that include drug dosages.”

Apple just screwed up! Now that they are vetting and credentialing health and medical apps they just became the target of patients and doctors liability lawsuits. Apple should return to being an agnostic platform and let the developers and the FDA take on the liability.

I’m in IT, focused on mHealth for a big pharma company and we’re very close to this issue. No, the FDA will NOT involve itself with information-centered apps that report dosing information obtained from the product’s label (labels are specific FDA-approved documents required for every pharma product, identified as “Prescribing Information”; these PI label docs can be found on every pharma product website, or via fed websites such as the NIH’s DailyMed). Medscape, PDR.net (online Physician’s Desk Reference), etc., use official PI’s. uCheck is a problem and is receiving FDA attention not because of dosing information, but because it is a DIAGNOSING tool…it uses the phone’s camera to interpret test strips. Yes, companies doing stuff like that submitting proof that their apps work will incur FDA attention.

Well, I’ll find out soon. I’m submitting one app for approval in a week, another in August, and both will have drug dosing with no relationship to the package insert. As usual following standard medical guidelines. –JSt

I have also experienced this with a Drug Reference App that I have been working on. It really creates a conundrum for generic drugs that can be produced by a range of manufacturers. In addition to this, the apps I have been working have been under the auspices of Government Health Departments and Internationally renowned hospitals: respected, impartial organisations. About to submit a Manual-style app which has a very small drug reference component. It will be interesting to see how that goes. @UNESCOCOT, surely a freely available medical textbook does not become a ‘Medical Device’ when presented on an iPad?

Interesting that Apple doesn’t take into account legitimate organizations recs as you’ve mentioned — that’s actually a great point. I kind of touched on this in the article. There is a lot of off label use of meds — especially in pediatrics. So if the dosing is not mentioned by the drug company, but is mentioned by a pediatric authority, is that not good enough?

The FDA is a tricky area – was just at the Mobile Computing in Medical Education conference and they had a 1hour session with 3 attorneys with FDA/medical device experience. In short, there is a lot of “grey” area with the current set of rules, but they said FDA involvement has to do with intent – i.e. if you’re reading a textbook with doses for education then no big deal…but if you’re pulling up that text for bedside dosing decisions, then that could fall under their purview. Fact-checking and ensuring valid data is of the utmost importance…but as this space is evolving so quickly, a pure black/white approach may not always be the best.

If Apple curtails ePocrates, Up To date, and iSilo files, then I would have to purchase Android and leave Apple forever. I doubt I would up grade our iPad2 to a 3 version, but go with the Android platform.

I cannot get a feel where this change in behavior is coming from. Is the root of this problem FDA or Apple or both?

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